Stress Urinary IncontinencePhase 1NCT00472069
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
A Phase 1 study testing transplantation of the squeletic muscular cells in people with Stress Urinary Incontinence and Urethral Intrinsic Sphincter Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stress Urinary Incontinence, Urethral Intrinsic Sphincter Deficiency
- What is being tested?
- transplantation of the squeletic muscular cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
- The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
- The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU > 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria.
- An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion
- For women: a negative BONNEY test, and Qtip test<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility.
- 24 hours Pad test > 20g.
Who cannot join
- Incapacity to answer the questionnaires of evaluation.
- History of pelvic radiotherapy.
- Disorder of hemostasis.
- Untreated urinary infection.
- Genetically determined or acquired muscular disease.
- Neurological disorder (Parkinson's disease, multiple sclerosis, spina BIFIDA, medullary traumatism).
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- The patients suffering from stress urinary incontinence due to vesica-urethral hypermobility (positive BONNEY test and Qtip test >40°) will not be included in the study because the referenced treatment is the implantation of a vaginal tape supporting the urethra.
- Incomplete vesical emptying. Residual volume > 20% of the urinated volume with a micturition >150cc.
- Dysuria: maximum urinary flow < 12 ml/sec, IPSS score>7 or score (men) or MHU dysuria domain none equal to 0 at woman.
- Vesical instability (bladder contraction > 10 cm H20 during the vesical filling of the cysto-manometry). bladder capacity (B3) < 300 DC.
- Urethral Stenosis (ureterocystoscopy).
- Previous surgeries for urinary incontinence do not constitute a criterion of exclusion.
- Pregnancy or intention of pregnancy throughout study. A test of pregnancy will be carried out with the visit of inclusion.
- Urethral diverticulum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS
Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra
Read the detailed description
stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells. The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter.
- Being tested
- transplantation of the squeletic muscular cells
- Keywords
- Stress Urinary Incontinence, striated urethral sphincter insufficiency, myofibers, satellite cells, myotubes, urethral, Muscle fibres
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of the squeletic muscular cellsProcedure or surgery
transplantation of the squeletic muscular cells
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | transplantation of the squeletic muscular cells Receives: Procedure: transplantation of the squeletic muscular cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells
Measured: 3 months
Secondary outcomes (1)
Effects of this treatment on urinary continence in order to consider a phase II later on.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- René YIOU, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472069
- Sponsor's protocol ID
- P060505
- Status last verified
- Sep 2007
- First submitted
- 10 May 2007
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS
- ClinicalTrials.gov ID
- NCT00472069
- Acronym / sponsor ID
- P060505
- Keywords
- Stress Urinary Incontinence, striated urethral sphincter insufficiency, myofibers, satellite cells, myotubes, urethral, Muscle fibres
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra
Detailed description
stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells. The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: transplantation of the squeletic muscular cellstransplantation of the squeletic muscular cells |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
- The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
- The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU > 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria.
- An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion
- For women: a negative BONNEY test, and Qtip test<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility.
Key exclusion criteria (14 listed)
- Incapacity to answer the questionnaires of evaluation.
- History of pelvic radiotherapy.
- Disorder of hemostasis.
- Untreated urinary infection.
- Genetically determined or acquired muscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transplantation of the squeletic muscular cellstransplantation of the squeletic muscular cells | Procedure or surgery | A |
Primary outcome
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells
Time frame: 3 months
1 secondary outcome
Effects of this treatment on urinary continence in order to consider a phase II later on.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René YIOU, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transplantation of the squeletic muscular cells in people with Stress Urinary Incontinence and Urethral Intrinsic Sphincter Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.